BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM

    MDR report key: 3370182 · Received September 26, 2013

    Report

    Report Number
    3003506883-2013-00361
    Event Type
    Injury
    Date Received
    September 26, 2013
    Report Date
    August 28, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF FINISHED PRODUCT DEVICE HISTORY RECORD (PART NUMBER 02.107.202, LOT NUMBER 7031990, WORK ORDER 3101273) DETERMINED THAT THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE. REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD (PART NUMBER 14065, LOT NUMBER 6851151) DETERMINED THAT THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE, WITH NO IRREGULARITIES DOCUMENTED. REVIEW OF THE RESPECTIVE RAW MATERIAL AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A VA-LCP OLECRANON PLATE, TWO 3.5MM SCREWS AND SIX 2.7MM SCREWS ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE DUE TO PIECES OF BONE AND SCREWS BACKING OUT OF THE LOCKING PLATE. NO INFORMATION WAS PROVIDED ON THE REVISION PROCEDURE. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487218 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM HRS SYNTHES ELMIRA 7031990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention